MODELS IDA-2 PLUS AND IPT-1— 510(k) K961862
Substantially Equivalent - Subject to Tracking Reg.Bio-Tek Instruments, Inc.
FDA 510(k) clearance K961862 for MODELS IDA-2 PLUS AND IPT-1, Substantially Equivalent - Subject to Tracking Reg. on 1997-02-26. Applicant: Bio-Tek Instruments, Inc..
Clearance details
- Applicant
- Bio-Tek Instruments, Inc.
- Product code
- Code FRN
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Winooski, VT, US
Adverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.